FlaggedRx← Medication recall checkHome
Class I · Most seriousActive recall

Famotidine

A reasonable chance it could cause serious harm or death.

Does this affect you?
Check your lot numberLot #: 6133156, 6133194, Exp Date: 08/2026; 6133388, Exp Date: 10/2026.
Where it was soldNationwide within the United States as well as AK, HI, and PR.
Find the lot number printed on your box or bottle. If it matches — and you take this medicine — call your pharmacist. Don't stop a prescribed medicine on your own.

What happened

Microbial Contamination of Sterile Products; out of limit results obtained for endotoxin testing.

What to do

  1. Check the lot number and expiry on your medicine against the recall above.
  2. Talk to your pharmacist or doctor before changing anything — don't stop on your own.
  3. Report any problems to FDA MedWatch (1-800-FDA-1088 or fda.gov/medwatch).

Who makes it

Made byFresenius Kabi USA, LLC
Brand nameFAMOTIDINE
Generic nameFAMOTIDINE
Active ingredient(s)FAMOTIDINE
Distributed by / forFresenius Kabi USA, LLC
NDC63323-739-11
Show the full FDA record
Full product labelFamotidine Injection, USP, 20 mg per 2 mL (10 mg per mL), 2 mL vials, Rx only, Fresenius Kabi USA, LLC, NDC 63323-739-11 (unit of use), 63323-739-12 (unit of sale).
Recalling firmFresenius Kabi USA, LLC
DistributionNationwide within the United States as well as AK, HI, and PR.
Quantity2,199,850 vials
Recall initiated2025-11-06
Report date2025-12-03
Recall completed—
Recall numberD-0182-2026
ClassificationClass I
FDA statusOngoing
Origin on fileLake Zurich IL United States

Related

Recent drug recallsCheck another medication

Source: U.S. FDA enforcement database (openFDA). Look this up on the official FDA recalls site ↗

This is public FDA recall information, not medical advice. A recall does not always mean your specific bottle is affected. Never stop a prescribed medicine without asking your pharmacist or doctor.